PMA P170006S037

Device: Avalus Bioprosthesis, Model 400
Applicant: Medtronic, Inc.
PMA number: P170006
Supplement: S037
Product code: LWR
Decision date: 2025-06-26
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: an increase in maximum occupancy, addition of workstations, and change in alert/action limits for non-viable particulate and surface microbial counts for Controlled Environmental Area (CEA) 36

Current openFDA PMA Record#

Device: Avalus Bioprosthesis, Model 400
Applicant: Medtronic, Inc.
PMA number: P170006
Supplement: S037
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-06-26
Decision code: OK30
Date received: 2025-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an increase in maximum occupancy, addition of workstations, and change in alert/action limits for non-viable particulate and surface microbial counts for Controlled Environmental Area (CEA) 36